The entrepreneur: Dr. Jim Boyd, 46, a dentist in San
Diego and founder of NTI-TSS Inc. in Misha-waka, Indiana, maker of the
NTI

Product description: FDA-approved for migraine
prevention, the NTI device is an inch-wide, custom-fitted night
guard that snaps onto the two front teeth to prevent back teeth
from clenching during sleep. The product sells to dentists for $20
per blank device; dentists typically purchase 10 blanks at a time,
then customize the product for each patient. (Fitting and
customization costs about $500, depending on the dentist.)

Startup: Boyd spent less than $15,000 developing the
product prior to licensing it to dental supplier Heraeus Kulzer in
1998. After the supplier invested more than $100,000 in the initial
product rollout and another $500,000 in clinical trials, it decided
not to continue with the product for financial reasons and offered
it back to Boyd in 2000 for $1 mil-lion. Heraeus Kulzer financed 70
percent of the sale, and Boyd raised the remaining 30 percent from
investors.

Sales: $4 million projected for 2005

The challenge: How does an individual, even a medical
professional, get a product to market if it requires FDA
approval?

Waking up with headaches and dealing with migraines several
times per week is a way of life for many people. These headaches
often result from the jaw clenching while sleeping. Dr. Jim Boyd,
who suffered from migraines himself, found in 1990 that putting a
small, custom-fitted device over the front teeth at night sets off
a reflex that stops clenching, greatly reducing or even eliminating
head-aches and migraines. Boyd figured a lot of people could
benefit from the NTI, so he set out to get the product to market--a
difficult task, considering it would need FDA approval. But Boyd
didn't back down, especially since he knew the product could
help a lot of people: According to NTI-TSS, 23 million people
suffer from severe migraine pain, and the NTI device helps more
than 75 percent of patients reduce migraines by more than 75
percent.

Steps to Success1. Use the invention in your practice. Boyd used the NTI for
eight years before licensing it to Heraeus Kulzer. "I had
treated patients with an NTI device, and documented the results for
well over 100 patients in my private practice," he says.
"Professionals are able to use a device without FDA approval
[known as off-label use] in their own practice. FDA approval is
only needed if you market the device with a medical claim."
While his records weren't used by the FDA for their approval,
they were available in case a potential licensee wanted evidence
that the NTI worked. If you're not a medical profes-sional,
partner up with one who will use the product in his or her
practice.

2. Get the word out. Boyd's practice specializes in
migraine relief. While he couldn't advertise the device itself
with a medical claim, he could promote his practice as one that
offers solutions for migraine sufferers. To get the word out, Boyd
placed ads in local newspapers announcing a "migraine
prevention breakthrough."

3. Protect yourself in royalty agreements. Royalty
agreements usually favor the company licensing the idea, but
inventors can often protect themselves with a minimum per-year
royalty that ensures they still collect even if the company
doesn't sell the product, or that they can get the product back
if minimum royalties aren't paid. Boyd used a different
approach: "I was able to negotiate a deal to get 33 percent of
sales as a royalty due to the product's high profit. That high
royalty played a role in the company's decision to sell the
patent rights back to me before the FDA clinical trials were
complete," he says. "They weren't convinced that the
product would ever gain FDA approval for migraine prevention, so
they sold [it] back to me."

4. Start with an application that has already been
approved. "FDA approvals are much simpler for medical
claims that have been made by other companies vs. a first-time
claim," says Boyd. "We received FDA approval to sell the
NTI device with a claim of correcting jaw disorders quickly and
with mini-mal clinical trials because other companies marketed
devices with similar claims. Two years of the product's sales
under that claim helped pay for clinical trials related to migraine
testing, and the sales encouraged the dental-supply house to keep
investing in trials."

5. Use professional articles to promote the concept.
Clinical trials are expen-sive, but they also form the basis for
technical articles that can be placed in key journals. Boyd ran an
active campaign to promote his idea to dentists through
professional journals. "For most of 2002 and 2003, dentists
received a quarterly dental journal with a promotional wrapper
describ-ing the NTI device, including large photographs of the
device in place," he says. "To date, over 15,000 dentists
have used the device with patients."

Lessons Learned1. Inventors can succeed with any type of product. Many
people discourage inventors from proceeding with inventions that
are difficult either because of regulatory hurdles, technology
challenges or strong market competition. But inventors do succeed
with all types of inventions--just look at companies like Medtronic
and Microsoft, which have grown into industry giants. You may need
more breaks and may need to persist longer before succeeding, but
there are no product categories in which an individual inventor
can't succeed.

2. It may take time to get the attention of industry
experts. People experienced in a market will recognize a novel
product if it meets a strong customer need or demand. Exhibiting at
trade shows, giving presentations at conferences, advertising where
people in the market can spot your ad and running publicity
programs are all techniques that will keep your idea in the public
eye. It may take several years, but if your product provides a
unique benefit, eventually someone who can help you launch the
product will notice.

3. When an inventor faces tremendous challenges, there are
often profits to be had. When Boyd needed to raise a large sum
of money, he could do it because the clinical trials showed the
product could provide relief to millions of migraine suffers. The
challenge was getting the trials conducted, but once Boyd had them,
he could target a large market. And he knew any potential
competitors would face a delay in seeking FDA approval.

4. You can almost always find a low-cost promotion
method. Articles published in professional dental journals
provided a great, low-cost promotion method for Boyd. Most
inventors use similar low-cost marketing strategies, such as PR in
consumer magazines, low-cost trade shows, or joint promotions an
inventor runs with other companies selling to the same market.
Check out the various promotional opportunities available before
you run an expensive promotional program, such as TV ads.

Looking For the Mother
Lode?
When mompreneur Tamara Monosoff successfully marketed her
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Monosoff recently wrote The Mom Inventors Handbook, (McGraw-Hill,
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requirements and inspirational stories on other mom inventors.